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510(k) K912244

UROTEST GPH by In Wha Pharmaceutical Co., Ltd. — Product Code JII

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1991
Date Received
May 21, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Atomic Absorption, Lithium
Device Class
Class II
Regulation Number
862.3560
Review Panel
TX
Submission Type

Other clearances for product code JII

  • K082001 — DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (December 5, 2008)
  • K033360 — DIAZYME LITHIUM ENZYMATIC ASSAY KIT (December 23, 2003)